Prognosis of Lung Transplant Candidates

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Kyoto University, Graduate School of Medicine
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00905463
First received: May 18, 2009
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.


Condition Intervention
Lung Transplantation
Respiratory Failure
Procedure: Lung transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Prognosis/Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health status [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Dyspnea [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Psychological status [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Sleep quality [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Pulmonary function [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Arterial blood gas [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Transplantation
Lung transplantation candidates
Procedure: Lung transplantation
Lung transplantation

Detailed Description:

The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

University hospital clinic for lung transplantation

Criteria

Inclusion Criteria:

  • New lung transplant candidates

Exclusion Criteria:

  • Heart and lung transplant candidates
  • Uncontrolled severe comorbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905463

Contacts
Contact: Fengshi Chen, MD, PhD +81 75 751 4975 fengshic@kuhp.kyoto-u.ac.jp
Contact: Toru Oga, MD, PhD +81 75 751 3852 ogato@kuhp.kyoto-u.ac.jp

Locations
Japan
Graduate School of Medicine, Kyoto University Recruiting
Kyoto, Japan
Contact: Fengshi Chen, MD, PhD    +81 75 751 4975    fengshic@kuhp.kyoto-u.ac.jp   
Contact: Toru Oga, MD, PhD    +81 75 751 3852    ogato@kuhp.kyoto-u.ac.jp   
Sub-Investigator: Toru Bando, MD         
Sub-Investigator: Izumi Matsumoto         
Sub-Investigator: Hiroaki Sakai, MD         
Okayama University Recruiting
Okayama, Japan
Principal Investigator: Takahiro Oto, MD         
Tohoku University Recruiting
Sendai, Japan
Principal Investigator: Katsunori Okada, M.D.         
Osaka University Recruiting
Suita, Japan
Principal Investigator: Masato Minami, MD         
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Hiroshi Date, MD, PhD Graduate School of Medicine, Kyoto University
  More Information

No publications provided

Responsible Party: Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00905463     History of Changes
Other Study ID Numbers: E554kyoto
Study First Received: May 18, 2009
Last Updated: March 25, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University, Graduate School of Medicine:
Lung transplant candidates
Health-related quality of life
patient reported outcome
Prognosis

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014